Surgical Access Devices and Methods Providing Seal Movement in Predefined Movement Regions

ABSTRACT

Various methods and devices are provided for allowing multiple surgical instruments to be inserted into sealing elements of a single surgical access device. The sealing elements can be movable along predefined pathways within the device to allow surgical instruments inserted through the sealing elements to be moved laterally, rotationally, angularly, and vertically relative to a central longitudinal axis of the device for ease of manipulation within a patient&#39;s body while maintaining insufflation.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/369,220 filed on Dec. 5, 2016 and entitled “Surgical Access Devicesand Methods Providing Seal Movement in Predefined Movement Regions,”which is a continuation of U.S. application Ser. No. 14/594,535 (nowU.S. Pat. No. 9,538,997) filed on Jan. 12, 2015 and entitled “SurgicalAccess Devices and Methods Providing Seal Movement in PredefinedMovement Regions,” which is a continuation of U.S. patent applicationSer. No. 12/399,656 (now U.S. Pat. No. 8,961,406) filed on Mar. 6, 2009and entitled “Surgical Access Devices and Methods Providing SealMovement in Predefined Movement Regions” which are hereby incorporatedby reference in their entireties.

FIELD OF THE INVENTION

The present invention relates to surgical access devices for providingsurgical access into a body cavity.

BACKGROUND OF THE INVENTION

Abdominal laparoscopic surgery gained popularity in the late 1980's,when benefits of laparoscopic removal of the gallbladder overtraditional (open) operation became evident. Reduced postoperativerecovery time, markedly decreased post-operative pain and woundinfection, and improved cosmetic outcome are well established benefitsof laparoscopic surgery, derived mainly from the ability of laparoscopicsurgeons to perform an operation utilizing smaller incisions of the bodycavity wall.

Laparoscopic procedures generally involve insufflation of the abdominalcavity with CO₂ gas to a pressure of around 15 mm Hg. The abdominal wallis pierced and a 5-10 mm diameter straight tubular cannula or trocarsleeve is then inserted into the abdominal cavity. A laparoscopictelescope connected to an operating room monitor is used to visualizethe operative field, and is placed through a the trocar sleeve.Laparoscopic instruments (graspers, dissectors, scissors, retractors,etc.) are placed through two or more additional trocar sleeves for themanipulations by the surgeon and surgical assistant(s).

Recently, so-called “mini-laparoscopy” has been introduced utilizing 2-3mm diameter straight trocar sleeves and laparoscopic instruments. Whensuccessful, mini-laparoscopy allows further reduction of abdominal walltrauma and improved cosmesis. Instruments used for mini-laparoscopicprocedures are, however, generally more expensive and fragile. Becauseof their performance limitations, due to their smaller diameter (weaksuction-irrigation system, poor durability, decreased video quality),mini-laparoscopic instruments can generally be used only on selectedpatients with favorable anatomy (thin cavity wall, few adhesions,minimal inflammation, etc.). These patients represent a small percentageof patients requiring laparoscopic procedures. In addition, smaller 2-3mm incisions may still cause undesirable cosmetic outcomes and woundcomplications (bleeding, infection, pain, keloid formation, etc.).

Since the benefits of smaller and fewer body cavity incisions areproven, it would be desirable to perform an operation utilizing only asingle incision in the navel. An umbilicus is well-hidden and thethinnest and least vascularized area of the abdominal wall. Theumbilicus is generally a preferred choice of abdominal cavity entry inlaparoscopic procedures. An umbilical incision can be easily enlarged(in order to eviscerate a larger specimen) without significantlycompromising cosmesis and without increasing the chances of woundcomplications. The placement of two or more standard (straight) cannulasand laparoscopic instruments in the umbilicus, next to each other,creates a so-called “chopstick” effect, which describes interferencebetween the surgeon's hands, between the surgeon's hands and theinstruments, and between the instruments. This interference greatlyreduces the surgeon's ability to perform a described procedure.

Thus, there is a need for instruments and trocar systems which allowlaparoscopic procedures to be performed entirely through the umbilicusor a surgical port located elsewhere while at the same time reducing oreliminating the “chopstick effect.”

SUMMARY OF THE INVENTION

The present invention generally provides devices for allowing surgicalaccess to an interior of a patient's body. In one embodiment, a surgicalaccess device is provided and can include a housing having a centralaxis and a working channel extending therethrough. A seal member can bedisposed in the housing and can be configured to seal the workingchannel. In addition, a plurality of sealing elements can be disposed inthe seal member and configured to receive and form a seal around aninstrument inserted therethrough and into the working channel. Theplurality of sealing elements can include at least one movable sealingelement that is movable independent of the other sealing elements withina predetermined path.

In some exemplary embodiments, the seal member can be rotatable aboutthe central axis of the housing to enable collective movement of theplurality of sealing elements. The surgical access device can alsoinclude a plurality of movable sealing elements wherein each of theplurality of movable sealing elements is movable independent of theother sealing elements within a predetermined path, such as an elongatetrack, that is unique to each movable sealing element. The movablesealing elements can be slidable within the elongate track and can bemovable in any direction within the elongate track. In one exemplaryembodiment, the elongate track can extend in a complete circle withinthe seal member and the sealing element can be movable around the circlewithin the track.

The seal member can have various configurations, for example, the sealmember can include a deformable membrane and at least a portion of eachsealing element can be integrally formed with the deformable membrane.Each sealing element can be angularly movable relative to a planarsurface of the housing such that a central axis of the sealing elementis non-parallel with the central axis of the housing. At least one ofthe sealing elements can have an opening with a diameter different thana diameter of an opening in the other sealing elements. In someembodiments, a retractor can extend from the housing and can have anopening formed therethough for receiving surgical instruments. Thehousing can optionally be rotatable relative to the retractor. Thesurgical access device can also include a safety shield extendingthrough the retractor and configured to protect the retractor from sharpsurgical instruments inserted therethrough.

In other aspects, a surgical access device is provided and can include ahousing having a central axis and a working channel extendingtherethrough, a seal member disposed within the housing and configuredto seal the working channel, and a plurality of sealing elementsdisposed in the seal member. The plurality of sealing elements can becollectively rotatable about the central axis of the housing, and atleast one sealing element can be independently movable within apredefined elongate pathway with respect to others of the plurality ofsealing elements. The sealing element can be movable in all directionswithin its predefined elongate pathway.

In some embodiments, the plurality of sealing elements can include aplurality of movable sealing elements and each movable sealing elementcan be configured for lateral and/or angular movement with respect tothe central axis of the housing. At least one of the sealing elementscan be configured to rotate 360 degrees about a central axis of thehousing. In addition, each sealing element can be angularly movablerelative to a planar surface of the housing such that a central axis ofthe sealing element is non-parallel with the central axis of thehousing.

The seal member can have various configurations and can include aflexible membrane that is configured to deform while maintaining a sealin response to movement of a surgical instrument inserted through one ofthe plurality of sealing elements. In some embodiments, a selectivelocking mechanism can be included that can be configured to selectivelylock a position of at least one of the sealing elements within the sealmember against movement in at least one direction. The selective lockingmechanism can also be configured to be unlocked to allow the position ofat least one sealing element within the seal member to be changed to anew position and can be configured to relock the sealing element againstmovement in at least one direction in the new position.

In another exemplary embodiment, a surgical access device is providedthat can include a flexible retractor having an opening extendingtherethrough and that is configured to be positioned within a surgicalincision, a housing coupled to a portion of the retractor that can berotatable relative to the retractor, and a base member disposed withinthe housing that includes a plurality of sealing elements formedtherein. The sealing elements can be configured to allow positioning ofsurgical instruments therethrough in a sealing arrangement. A majorityof the sealing elements can be movable sealing elements that are movableindependent of the other of the plurality of sealing elements within apredefined movement region within the base member.

In some embodiments, the base member can include an upper bearing plateand a lower bearing plate. Each bearing plate can have predefinedmovement regions formed therein to guide movement of the movable sealingelements. The base member can further include a deformable seal memberdisposed between the upper and lower bearing plates that is effective toseal a working channel extending through the housing and the retractor.The plurality of sealing elements can optionally each include a flexiblesealing membrane integrally formed with the deformable seal member andconfigured to form a seal around a surgical instrument insertedtherethrough.

In one embodiment, the plurality of sealing elements can each include anupper seal support and a lower seal support that are configured to matetogether such that the flexible sealing membrane of the sealing elementis coupled between the upper and lower seal supports. The upper sealsupport can be movable within the predefined movement region formed inthe upper bearing plate and the lower seal support can be movable withinthe predefined movement region formed in the lower bearing plate. Thesurgical access device can also include an insufflation port extendingfrom a side wall of the housing and configured to provide insufflationinto a body through a working channel extending through the housing andthe retractor.

In other aspects, methods for accessing a surgical site within a bodyare also provided and can include inserting a flexible retractor of asurgical access device into an opening in a body in proximity to aninterior surgical site, inserting a surgical instrument into a sealingelement disposed within a sealing member of a housing of the surgicalaccess device such that the surgical instrument extends through aworking channel of the surgical access device and into the interiorsurgical site, and moving the surgical instrument laterally and/orangularly to cause corresponding lateral and/or angular movement of thesealing element within a predefined pathway formed in the housing tobetter access the interior surgical site.

In some embodiments, moving the surgical instrument laterally and/orangularly to cause corresponding lateral and/or angular movement of thesealing element within a predefined pathway can include stretching andpushing the sealing member. In other embodiments, moving the surgicalinstrument laterally can cause corresponding lateral movement of thesealing element within a predefined pathway and can include moving thesealing element from a center portion of the predefined pathway to oneend of the predefined pathway.

Certain exemplary methods can also include inserting a second surgicalinstrument into a second sealing element disposed within the sealingmember of the housing of the surgical access device such that the secondsurgical instrument extends through the working channel of the surgicalaccess device and into the interior surgical site. The method canfurther include moving the second surgical instrument laterally and/orangularly to cause corresponding lateral and/or angular movement of thesecond sealing element within a second predefined pathway independentlyof the surgical instrument within the predefined pathway.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective view of one embodiment of a surgical accessdevice having sealing elements disposed in predefined paths;

FIG. 2 is top view of the surgical access device of FIG. 1;

FIG. 3 is an exploded view of the surgical access device of FIG. 1;

FIG. 4 is an exploded view of a base member included in the surgicalaccess device of FIG. 1;

FIG. 5 is a cross-sectional view of the surgical access device of FIG.1;

FIG. 6 is a cross-sectional view of a sealing member of the surgicalaccess device of FIG. 1;

FIG. 7 is another cross-sectional view of the surgical access device ofFIG. 1;

FIG. 8 is another cross-section view of the sealing membrane of thesurgical access device of FIG. 1

FIG. 9 is a perspective view of the surgical access device of FIG. 1with a surgical instrument disposed through a sealing element andpositioned at an angle with respect to a central longitudinal axis ofthe surgical access device;

FIG. 10 is a cross-section view of the surgical access device of FIG. 1showing a surgical instrument disposed through a sealing element andpositioned at an angle with respect to the central longitudinal axis ofthe surgical access device;

FIG. 11 is a perspective view of the surgical access device of FIG. 1disposed in tissue and having three surgical instruments disposedthrough three sealing elements;

FIG. 12 is a perspective view of the surgical access device of FIG. 1disposed in tissue and having three surgical instruments disposedthrough three sealing elements at various angles;

FIG. 13 is a cross-sectional view of the surgical access device of FIG.1 showing surgical instruments disposed through the sealing elements;

FIG. 14 is a perspective view illustrating a first range of motion ofthe surgical access device of FIG. 1;

FIG. 15 is a perspective view illustrating a second range of motion ofthe surgical access device of FIG. 1;

FIG. 16 is a perspective view illustrating a third range of motion ofthe surgical access device of FIG. 1;

FIG. 17 is a perspective view illustrating all three ranges of motion ofFIGS. 17-19;

FIG. 18 is a perspective view of the surgical access device of FIG. 1disposed in tissue with a surgical instrument disposed within a sealingelement;

FIG. 19 is a perspective view of a housing support and a retractor ofthe surgical access device of FIG. 1 disposed in tissue with a topportion of the housing detached therefrom;

FIG. 20 is a cross-sectional view of tissue being removed through theretractor and the housing support of the surgical access device of FIG.1;

FIG. 21 is a cross-sectional view of the surgical access device of FIG.1 including one embodiment of a safety shield;

FIG. 22 is a perspective view of the safety shield of FIG. 21;

FIG. 23 is an exploded view of the safety shield of FIG. 21;

FIG. 24 is a cross-sectional side view of a second embodiment of asafety shield;

FIG. 25 is a cross-sectional top view of the safety shield of FIG. 24;

FIG. 26 is a cross-sectional side view of a third embodiment of a safetyshield;

FIG. 27 is a cross-sectional top view of the safety shield of FIG. 26;

FIG. 28 is a perspective view of the safety shield of FIG. 26;

FIG. 29A is a cross-sectional view of another embodiment of a basemember of a surgical access device having rotatable sealing elements;

FIG. 29B is an exploded view of the base member of FIG. 29A illustratingrotatable rims for rotating the sealing elements;

FIG. 30 is one embodiment of locking mechanism for preventing rotationof the rotatable rims of FIG. 29B;

FIG. 31A is a perspective view of one embodiment of a base member withmultiple rotatable rings;

FIG. 31B is a top view of the base member of FIG. 31A showing movableflexible arms;

FIG. 31C is a cross-sectional view of the base member of FIG. 31A;

FIG. 31D is a top view of the base member of FIG. 31A;

FIG. 31E is a perspective view of an adjustment mechanism of the basemember of FIG. 31A.

FIG. 32A is a cross-sectional view of a base member of a surgical accessdevice having a flush sealing element;

FIG. 32B is a cross-sectional view of a base member of a surgical accessdevice having a recessed sealing element;

FIG. 33A is a perspective view of a base member having a flexiblebellows sealing member;

FIG. 33B is a top view of the base member of FIG. 33A;

FIG. 34A is an exploded view of three rotatable base members havingsealing elements therein;

FIG. 34B is a cross-sectional view of the base members of FIG. 34Apositioned in a housing;

FIG. 35A is a cross-sectional view of an exemplary base member havingmultiple layers of sealing elements;

FIG. 35B is a perspective view of the base member of FIG. 35A;

FIG. 36A is an exploded view of a base member having a flexible sealingmembrane and a plurality of rotatable rims;

FIG. 36B is a perspective view of the base member of FIG. 36A;

FIG. 37A is a cross-sectional view of a gimbal seal;

FIG. 37B is a perspective of the gimbal seal of FIG. 37A having aninstrument positioned therein;

FIG. 37C is a perspective of the gimbal seal of FIG. 37A;

FIG. 37D is another perspective view of the gimbal seal of FIG. 37A.

FIG. 38A is a top view of one embodiment of a base member having tracksformed therein;

FIG. 38B is a perspective view of the base member of FIG. 38A;

FIG. 38C is a cross-sectional view of a sealing element in the basemember of FIG. 38A;

FIG. 39A is a top view of another embodiment of a base member havingrotatable rims; and

FIG. 39B is a cross-sectional view of the base member of FIG. 39A.

DETAILED DESCRIPTION OF THE INVENTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of skilled in the art will understand that the devicesand methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

The present invention generally provides improved surgical accessdevices that allow multiple surgical instruments to be inserted intosealing elements of a single surgical access device. The improvedsurgical access devices allow surgical instruments inserted through thesealing elements to be moved laterally, rotationally, angularly, andvertically for ease of manipulation within a patient's body whilemaintaining insufflation.

In certain exemplary embodiments, a housing is provided having a basemember with a plurality of sealing elements coupled thereto forreceiving and forming a seal around surgical instruments insertedtherein. The base member can provide one or more predetermined paths,predefined movement regions, and/or predefined elongate pathways thatcan guide lateral, independent movement of the sealing elements therein,thereby allowing for lateral movement of surgical instruments insertedwithin the sealing elements. The housing can define a centrallongitudinal axis, and the plurality of sealing elements can each have acentral axis that can be angularly adjustable relative to the centrallongitudinal axis of the housing within the predetermined paths of thebase member, thereby allowing a surgeon more control over the insertionof multiple surgical instruments. In some embodiments, the plurality ofsealing elements can be collectively rotated about the central axis ofthe housing to enable greater surgeon maneuverability within the device.

The various surgical access devices can further include a woundprotector, cannula, ring retractor, or other member for forming apathway through tissue (hereinafter generally referred to as aretractor). The retractor can extend from the housing and it can beconfigured to be positioned within an opening in a patient's body. Thesealing elements can each define working channels extending through thehousing that are generally aligned with the retractor. Any and all ofthe surgical access devices described herein can also include variousother features, such as one or more ventilation ports to allowevacuation of smoke during procedures that utilize cautery and/or one ormore insufflation ports through which the surgeon can insufflate theabdomen to cause pneumoperitenium, as described for example in U.S.Patent Application No. 2006/0247673 entitled “Multi-port LaparoscopicAccess Device” filed Nov. 2, 2006 and incorporated herein by referencein its entirety. The insufflation port can be any size and can accept aleur lock or a needle, as will be appreciated by those skilled in theart.

In use, the surgical access devices disclosed herein can be utilized toprovide access to a patient's body cavity. The retractor can bepositionable within an opening in a patient's body such that a distalportion of the retractor extends into a patient's body cavity and aproximal portion is coupled to a housing positioned adjacent to thepatient's skin on an exterior of the patient's body. A lumen in theretractor can form a pathway through the opening in a patient's body sothat surgical instruments can be inserted from outside the body, throughthe sealing elements, to an interior body cavity. The elasticity of theskin of the patient can assist in the retention of the retractor in thebody opening or incision made in the body. The retractor can be placedin any opening within a patient's body, whether a natural orifice or anopening made by an incision. In one embodiment, the retractor can besubstantially flexible so that it can easily be maneuvered into andwithin tissue as needed. In other embodiments, the retractor can berigid or semi-rigid. The retractor can be formed of any suitablematerial known in the art, for example silicone, urethane, thermoplasticelastomer, and rubber.

Typically, during surgical procedures in a body cavity, such as theabdomen, insufflation is provided through the surgical access device toexpand the body cavity to facilitate the surgical procedure. Thus, inorder to maintain insufflation within the body cavity, most surgicalaccess devices include at least one seal disposed therein to prevent airand/or gas from escaping when surgical instruments are insertedtherethrough. Some of the embodiments disclosed herein can be used withonly one type of seal, for example an instrument seal, that prevents airand/or gas from escaping when a surgical instrument is insertedtherethrough, but otherwise does not form a seal when no instrument isdisposed therethrough. Other embodiments can include various sealingelements that are known in the art, and can include at least oneinstrument seal, at least one channel seal or zero-closure seal thatseals the working channel created by the sealing port when no instrumentis disposed therethrough, and/or a combination instrument seal andchannel seal that is effective to both form a seal around an instrumentdisposed therethrough and to form a seal in the working channel when noinstrument is disposed therethrough. A person skilled in the art willappreciate that various seals known in the art can be used including,for example, duckbill seals, cone seals, flapper valves, gel seals,diaphragm seals, lip seals, gimbal seals, deep cone seals, iris seals,slit seals, etc. A person skilled in the art will also appreciate thatany combination of seals can be included in any of the embodimentsdescribed herein, whether or not a particular seal combination isspecifically discussed in the corresponding description of a particularembodiment.

One aspect of the embodiments disclosed herein is that exemplarysurgical access devices provide for greater maneuverability of surgicalinstruments within a patient while maintaining insufflation. In oneembodiment, this greater maneuverability can be provided by havingpredefined movement regions, predefined elongate pathways, tracks,and/or predetermined paths formed within the housing that allow sealingelements, and surgical instruments disposed within the sealing elements,to be independently moved within and/or along the predetermined paths toallow for a greater range of motion. In addition, the sealing elementscan be angled relative to the predetermined paths to allow for angularmanipulation of the surgical instruments as well as lateral movementalong the predefined paths. In some embodiments, each sealing elementcan include a flexible sealing membrane that can be integrally formedwith a flexible sealing member. The flexible sealing member can providea gas tight seal within the housing and across the working channel andcan stretch, twist, bunch, and otherwise deform to allow the sealingelements to move laterally, angularly, and vertically within theirpredetermined paths and relative to other sealing elements. In addition,the entire sealing member can be rotated 360 degrees to thereby rotatethe sealing elements to allow a change in position of surgicalinstruments inserted through the sealing elements. It will beappreciated by those skilled in the art that any of the various aspectsand features of the surgical access device embodiments described hereincan be used in and applied to any and all of the various otherembodiments, to various devices known in the art, or to devices yet tobe developed.

One exemplary embodiment of a surgical access device 10 is illustratedin FIGS. 1-6. As shown, the surgical access device 10 can generallyinclude a housing 12 with a retractor 28 extending distally therefrom.The housing 12 and the retractor 28 can define a working channelextending therethrough and a central longitudinal axis 30. The housing12 can generally include one or more sealing elements 18 and/or sealingmembers 48 and the retractor 28 can be configured to be positionedwithin an opening in a patient's body to provide access to an interiorsurgical site. The tissue surrounding an opening in which the retractor28 is placed can exert a pressure on the retractor 28 to hold theretractor 28 in place within a body such that the housing 12 ispositioned against tissue on the exterior of the body. In this way, anaccess pathway to an interior surgical site is created through whichsurgical instruments can be inserted to perform a surgical procedure.

As noted above, the retractor 28 can extend from the housing, and in oneembodiment, the retractor 28 is a substantially flexible member having aproximal flange 32 and a distal flange 34 with an inner elongate portion36 extending therebetween. The proximal flange 32 can be positionedwithin a distal portion of the housing 12. A proximal o-ring 38 can beincluded within the proximal flange 32 to add structural support to theproximal flange 32 and to aid in allowing rotation of the housing 12relative to the retractor 28, as will be described in more detail below.A distal o-ring 40 can optionally be included within the distal flange34 of the retractor 28 to provide structural support to the retractor 28within a patient's body. The proximal and distal o-rings 38, 40 can beflexible or substantially rigid as needed for use in a particularapplication.

Referring particularly to FIG. 3, the device 10 can include a housingcover 14 and a housing support 42 that can be mated together togenerally form the structure of the housing 12. The housing 12 canfurther include a base member 16 and a base member support 44 securedbetween the housing cover 14 and the housing support 42. In someembodiments, the housing cover 14 can be formed of a crown 20 and coverflange 22 with one or more latches 24 extending from the cover flange 22to aid in securing the housing cover 14 to the housing support 42. Thecrown 20 of the housing cover 14 can generally serve as a top mostportion of the housing 12 and is in the shape or form of a ring definingan opening 46 in the housing cover 14 that allows access to the sealingelements 18. The crown 20 can have a diameter that is, for example,smaller than a diameter of the cover flange 22. In other embodiments,the crown 20 can have a diameter that is the same as, or larger than, adiameter of the cover flange 22 depending on the requirements of aparticular surgical access device.

In the illustrated embodiment, the crown 20 and the cover flange 22 areintegrally formed as a single component and the cover flange 22 extendsdistally at an angle from the crown 20 in an expanding diameter. Inother embodiments, the crown 20 and the cover flange 22 can be adheredand/or fastened together with any mating mechanism known in the art,such as adhesive, screws, threads, etc. The cover flange 22 can have aring-like shape with a diameter that can generally define an outerdiameter or outer circumference of the housing 12. A distal surface 50of the cover flange 22 can be substantially level or flat to enableflush mating with an outer rim 52 of the base member support 44. A notch26 can be formed in the cover flange 22 to receive an insufflationaccess port 54 formed in the base member support 44 that can receive aninsufflation port 56. One or more apertures or openings 58, shown inFIGS. 5 and 6, can be formed into the cover flange 22 around acircumference thereof to enable further mating between the housing cover14 and the base member support 54, as will be described in more detailbelow. In some embodiments, the openings 58 in the cover flange 22 canextend upward or proximally from the distal surface 50 of the coverflange 22 to a lower or distal surface 60 of the crown 20. As will beappreciated by those skilled in the art, any number of mating orcoupling mechanisms can be formed in and/or around the housing cover 14to allow mating with other components of the housing 12.

As noted above, one or more latches 24 can extend from the cover flange22 of the housing cover 14 to allow the housing cover 14 to mate orcouple with the housing support 42. As shown most clearly in FIGS. 5 and6, the latches 24 can include a recessed groove 62 having an inner lip64 that can support and seat an outer rim 66 formed by a recessedportion 68 of the housing support 42. The recessed groove 62 within thelatch 24 can also receive a recessed lip 70 of the base member support44 seated on top of the outer rim 66, thereby securing all components ofthe housing 12 together. An outer lip 72 of the latch 24 allows for thelatch 24 to be manually moved outward and upward, as indicated by thedirectional arrow A in FIG. 5, to enable the housing cover 14 to beunlatch from the rest of the housing 12. As will be appreciated, anynumber of mating and/or coupling mechanisms can be used to mate thehousing cover 14 with the rest of the housing 12, including but notlimited to, adhesives, threads, screws, bayonet latches, etc.

Referring to FIGS. 3, 5, and 6, the housing support 42 is illustrated asa generally ring-shaped member having a seating flange 74 with acircumferential sidewall 76 extending proximally from an outercircumference of the seating flange 74. The seating flange 74 can beconfigured to seat the proximal flange 32 of the retractor 28 such thata top surface 78 of the proximal flange 32 is positioned slightly belowa top surface 80 of the circumferential sidewall 76. The proximal flange32 can generally be seated within the housing support 42 without the aidof any securement mechanism in order to allow the housing 12 to be movedrelative to the retractor 28. Thus, the proximal flange 32 of theretractor 28 can have a diameter smaller than a diameter of thecircumferential sidewall 76, and in some embodiments, can have adiameter significantly smaller than a diameter of the circumferentialsidewall 76 to allow for both lateral, sliding movement and rotational,sliding movement of the housing 12 relative to the retractor 28. Inother embodiments, the diameter of the proximal flange 32 can be onlyslightly smaller than a diameter of the circumferential sidewall 76 toprevent such lateral, sliding movement while still allowing forrotational, sliding movement. The housing support 42 can optionallyinclude one or more frictional protrusions 82 extending inward from aninner surface 84 of the circumferential sidewall 76 to provide a surfaceagainst which the proximal flange 32 can move as the housing 12 is beingmoved or rotated relative to the retractor 28. As shown, the innerelongate portion 36 of the retractor 28 can extend proximally throughthe opening formed in the housing support 42, thereby defining theworking channel through which instruments can be inserted.

While the housing support 42 can have many configurations, in theillustrated embodiment, the top surface 80 of the circumferentialsidewall 76 has a diameter equal to a diameter of the base membersupport 44 and can thus sit flush against a bottom or distal surface 86of the base member support 44. The sidewall 76 can also have otherdiameters smaller or larger than the base member support 44 as needed ina particular application. As previously noted, the housing support 42can have one or more recessed portions 68 formed in the circumferentialsidewall 76 for mating with one or more latches 24 of the housing cover14. The proximal outer rim 66 of the recessed portion 68 can be seatedby the inner lip 64 of the recessed grooves 62 of the latches 24extending from the housing cover 14.

As also noted above, the base member 16 and the base member support 44can be secured between the housing cover 14 and the housing support 42.The base member 16 can generally be seated or disposed within the basemember support 44, and the base member support 44 can provide theconnection or coupling to the housing cover 14 and the housing support42. As shown in FIGS. 3, 5, and 7 the base member support 44 has aplanar flange portion in the shape of a ring with a circular sidewall 88extending proximally from the planar flange portion such that the flangeportion is divided into two sections. A first section or inner rim 90forms a seating area with the sidewall 88 for receiving and seating thebase member 16. The second section or outer rim 52 provides matingelements for mating the base member support 42 to the housing cover 14.

In some embodiments, an inner surface 94 of the sidewall 88 can includethreads formed therearound and/or another engagement mechanism formating with corresponding threads or engagement mechanisms formed on anouter circumference 92 of the base member 16, thereby securing the basemember while still allowing rotation thereof. In the illustratedembodiment, the base member 16 fits securely within the base membersupport 44 through a loose press fit and/or interference fit connectionbetween the outer circumference 92 of the base member 16 and the innersurface 94 of the sidewall 88. The loose press fit or interference fitcan be such that the base member 16 is freely rotatable in bothdirections relative to the base member support 42 and the rest of thehousing 12. Rotation of the base member 16 relative to the base membersupport 42 and the housing 12 allows rotation of all of the sealingelements 18 disposed within the base member 16 as a unit, as will bedescribed further below.

There are many ways in which the base member support 42 and the housingcover 14 can be joined, but in one embodiment, the outer rim 52 of thebase member support 42 can include one or more mating protrusions 96extending therefrom for mating with one or more corresponding openings58 in the housing cover 14. A press fit, interference fit, and/oradhesive, for example, can be used to join the protrusions 96 with theopenings 58 in the housing cover 14. When secured between the housingcover 14 and the housing support 42, a proximal or top surface of theouter rim 52 can be positioned adjacent to the distal surface 50 of thecover flange 22. The outer rim 52 can have an outer circumference thatis substantially flush with the outer circumference of the cover flange22. The distal or bottom surface 86 of the outer rim 52 can bepositioned adjacent to the top surface 80 of the circumferential wall 76of the housing support 42, and its outer circumference can also besubstantially flush with the outer circumference of the housing support42. One or more recessed slots 70 can be formed around an outercircumference of the outer rim 52 to correspond with the recessedportions 68 formed in the housing support 42 for receiving the housingcover latch 24. As noted above, the recessed portion 68 can be securelygrasped on top of the outer rim 66 of the housing support 42 within thegroove 62 of the latch 24.

The insufflation access port 54 can be formed in the base member support44 and can consist of an opening 100 extending from the outercircumference of the outer rim 52 and through the sidewall 88 into theworking channel. The opening 100 can receive the insufflation port 56for introducing insufflation gases through the working channel and intoa body. The opening 100 can extend into the working channel at aposition below or distal to the base member 16 and the sealing elements18 disposed in the base member 16. In this way, insufflation gases canbe introduced and retained in the working channel and body by thesealing elements 18 when surgical instruments are inserted therethrough.In the illustrated embodiment, the insufflation port 56 extendsperpendicularly to the central longitudinal axis 30 of the housing 12,but as will be appreciated by those skilled in the art, insufflationaccess ports 54 can be positioned at any suitable place within thehousing 12. In addition, the insufflation ports 56 can extend from thehousing 12 at any angle relative to its central longitudinal axis 30,including parallel thereto.

Referring now to FIGS. 1 and 4, the various components of the exemplarybase member 16 are illustrated in more detail. As shown, the base member16 can include an upper bearing plate 102, a lower bearing plate 104,and the sealing member 48 disposed between the two bearing plates 102,104. The sealing elements 18 can extend through the sealing member 48and the bearing plates 102, 104, as will be described in more detailbelow. The upper and lower bearing plates 102, 104 can each include oneor more predefined movement regions, predefined elongate pathways,predetermined paths, and/or tracks formed therein that are provided toguide movement of the sealing elements 18. The bearing plates 102, 104are generally each substantially flat, circular elements that, in someembodiments, can be substantially rigid. In other embodiments, one orboth of the bearing plates 102, 104 can be substantially flexible asneeded in a particular application. Each bearing plate 102, 104 can beformed of any suitable material known in the art, including but notlimited to, polycarbinate and/or high density polyethelene. In theillustrated embodiment, three generally elongate tracks 106, 108, 110are provided in the upper and lower bearing plates 102, 104 forreceiving three movable sealing elements 18 a, 18 b, 18 c therein. Inaddition, a fourth, generally circular opening 112 is provided toreceive a more constrained, non-movable sealing element 18 d therein. Aswill be appreciated by those of skill in the art, any number of trackscan be disposed in the bearing plates 102, 104 as needed.

While the tracks 106, 108, 110 can have any size, shape, length, andcurvature known in the art, in the illustrated embodiment, the tracks106, 108, 110 are generally elongate and have a width substantiallycorresponding to a diameter of the sealing element 18 disposed thereinand a length corresponding to between about one and a half to two timesthe diameter of the sealing element 18 disposed therein. In otherembodiments, the tracks 106, 108, 110 can have a width and/or a lengthcorresponding to anywhere between about two to five times a diameter ofthe sealing element 18 disposed therein. The number of tracks within abearing plate can range between one and any number (two, three, four,five, six, etc.) that can reasonably fit within a diameter of thebearing plates 102, 104. Thus, a single track formed within the basemember 16 can have a substantially large size relative to the size ofthe bearing plates 102, 104, while multiple tracks formed within thebase member 16 can have a smaller size relative to the size of thebearing plates 102, 104. Multiple tracks can also have substantiallydifferent sizes from one another.

The tracks 106, 108, 110 can generally be positioned and spaced withinthe upper and lower bearing plates 102, 104 in any way as needed in aparticular application. In the embodiment shown in FIGS. 1-6, a firsttrack 106 is a substantially straight track and extends from a positionadjacent to an outer diameter of the upper and lower bearing plates 102,104 into a center portion of the plates 102, 104. Second and thirdtracks 108, 110 can be positioned on opposite sides of the first track106 and can also extend from a position adjacent to an outer diameter ofthe upper and lower bearing plates 102, 104. As shown, the second andthird tracks 108, 110 curve slightly inward around a portion of thefirst track 106 that extends into the center of the bearing plates 102,104. The fourth opening 112 is disposed at a position substantiallyopposite to a position of the first track 106. In other embodiments, thetracks 106, 108, 110 can be situated around a diameter of the bearingplates 102, 104 or, as shown in FIGS. 38A-38C, tracks 106′, 108′, 110′can all extend from an outer diameter into a center of the bearingplates 102′, 104′. As shown, the bearing plates 102′, 104′ can have asealing element 18′ formed therein with a flexible sealing member 48′therearound. In addition, in some embodiments all of the tracks 106,108, 110 can be straight and in other embodiments, all of the tracks106, 108, 110 can have a curvature. There are many configurationspossible for the shape and positioning of the tracks 106, 108, 110within the bearing plates 102, 104 and such configurations should not belimited to the several that are noted herein.

In the illustrated embodiment, the upper bearing plate tracks 106 a, 108a, 110 a can have smooth interior sidewalls 116 to enable smoothmovement of the movable sealing elements 18 a, 18 b, 18 c within theupper bearing plate tracks 106 a, 108 a, 110 a. In addition, the lowerbearing plate tracks 106 b, 108 b, 110 b can have interior sidewallswith a smooth proximal portion 114 corresponding in size to thesidewalls 116 of the upper bearing plate tracks 106 a, 108 a, 110 a toenable smooth movement of the sealing elements 18 a, 18 b, 18 c withinthe tracks 106 b, 108 b, 110 b. A lower or distal portion 118 of thesidewalls can extend or protrude slightly into the tracks 106 b, 108 b,110 b to form a lip extending therearound that has a size slightlysmaller than a size of the proximal portion 114 and a size of thesidewalls 116 of the upper bearing plate tracks 106 a, 108 a, 110 a. Thesealing elements 18 a, 18 b, 18 c can move and/or slide along the lipformed in the lower bearing plates tracks 106 b, 108 b, 110 b andvertical and/or longitudinal movement of the sealing elements 18 a, 18b, 18 c below the lower bearing plate tracks 106 b, 108 b, 110 b isrestrained or prohibited while vertical and/or longitudinal movement ofthe sealing elements 18 a, 18 b, 18 c above the upper bearing platetracks 106 a, 108 a, 110 a is not restrained or prohibited. In otherembodiments, the sidewalls 116, 114, 118 of the upper and lower bearingplate tracks 106 a, 106 b, 108 a, 108 b, 110 a, 110 b are completelysmooth, with no lip, such that vertical and/or longitudinal movementbelow and above the tracks is allowed.

In other exemplary embodiments, engagement elements, such as grooves orrecesses, can extend around the sidewalls 116, 114, 118 in the upperand/or lower bearing plate tracks 106 a, 106 b, 108 a, 108 b, 110 a, 110b that are configured to mate with corresponding engagement elementsformed around the sealing elements 18 a, 18 b, 18 c to provideconstrained vertical and/or longitudinal movement of the sealingelements 18 a, 18 b, 18 c while allowing lateral, guided movement withinthe tracks 106, 108, 110. A person skilled in the art will appreciatethe various ways of allowing or preventing movement of the sealingelements 18 a, 18 b, 18 c within the bearing plate tracks 106, 108, 110as needed for a particular application. In addition, one or more tracks106, 108, 110 can provide constrained movement of a sealing element 18a, 18 b, 18 c disposed therein while one or more tracks 106, 108, 110can provide a full range of movement and/or motion of a sealing element18 a, 18 b, 18 c disposed therein.

The upper and lower bearing plates 102, 104 can be joined or coupledtogether by any method known in the art, including but not limited to,adhesive, screws, press fit, interference fit, etc. In the illustratedembodiment, one or more cylindrical protrusions 120 and one or moreelongate protrusions 122 are formed around an outer rim 124 of the lowerbearing plate 104 such that they extend proximally therefrom. Thecylindrical protrusions 120 are configured to extend through securementopenings 126 formed around an outer diameter of the sealing member 48and into corresponding openings 128 formed around an outer diameter ofthe upper bearing plate 102 such that a press fit or interference fit isachieved between the cylindrical protrusions 120 and the openings 128 inthe upper bearing plate 102. The elongate protrusions 122 are configuredto secure the lower bearing plate 104 to the sealing member 48 and thusextend into corresponding elongate slots 130 formed around the outerdiameter of the sealing member 48. In this way, the base member 16 issecured together with the sealing member 48 coupled between the upperand lower bearing plates 102, 104.

The sealing member 48 can have many configurations and in theillustrated embodiment, the sealing member 48 generally seals theworking channel of the surgical access device 10 by providing an air andgas tight seal between the upper bearing plate 102 and the lower bearingplate 104. The sealing member 48 can be composed of a flexible,stretchable, and/or deformable material that is able to flex, stretch,bunch and/or otherwise deform to allow the sealing elements 18 a, 18 b,18 c disposed therethrough to be moved within their respective tracks106, 108, 110 within the bearing plates 102, 104. In the illustratedembodiment, the sealing member 48 is a relatively thin, deformablemembrane that has a diameter corresponding to a diameter of the upperand lower bearing plates 102, 104 such that it can be positioned andform a seal between the upper and lower bearing plates 102, 104. Thesealing member 48 can be formed of any suitable material known in theart, including but not limited to, silicone, urethane, sanaprene,isoprene, and/or krayton.

The sealing member 48 can include one or more openings 132 formedtherethrough that define openings for one or more sealing elements 18.As noted above, each sealing element 18 can be a movable sealingelement, for example, movable sealing elements 18 a, 18 b, 18 c, or anon-movable sealing element, for example, non-movable sealing element 18d. Movable sealing elements 18 a, 18 b, 18 c are generally configured tobe independently movable within their respective bearing plate tracks106, 108, 110 relative to the housing, each other, and to non-movablesealing elements. The non-movable sealing element 18 d is generallyconfigured to be secured within a circular opening, for example, opening112, in the bearing plates 102, 104 that does not provide room for thesealing element 18 d to move. In some embodiments, the movable sealingelements 18 a, 18 b, 18 c compose a majority of the total number ofsealing elements 18 disposed within the base member 16. In addition, oneor more sealing elements 18 can have an opening with a differentdiameter than an opening of the other sealing elements 18. For example,one or more movable sealing elements 18 a, 18 b, 18 c can have anopening with a diameter that is the same as, larger than, or smallerthan openings in other movable sealing elements 18 a, 18 b, 18 c and inother non-movable sealing element 18 d. One or more non-movable sealingelements 18 d can have an opening with a diameter that is the same as,larger than, or smaller than openings in other non-movable sealingelements (not shown) and in other movable sealing elements 18 a, 18 b,18 c.

The sealing elements 18 can have many configurations and constructions,but in the illustrated embodiment, the sealing elements 18 each includea sealing membrane 134, formed integrally with the sealing member 48,that is configured to form a seal around a surgical instrumentpositioned therethrough. The sealing membrane 134 can generally have acone-like shape with flexible conical walls 136 and an opening 138,shown most clearly in FIGS. 5 and 6, at the apex of the cone that issmaller than a diameter of a surgical instrument such that the opening138 can deform to form a seal around an instrument insertedtherethrough. Each sealing membrane 134 can be the same as every othersealing membrane 134 or one or more sealing membranes 134 can bedifferent than another. As shown in FIGS. 5-8, the sealing membrane 134of sealing element 18 a can have a fluted form in which the conicalwalls 136 are folded in v-shaped, accordion style folds. Thisconstruction assists in preventing eversion of the sealing membrane 134when an instrument is withdrawn from the sealing element 18 a. Inparticular, as shown most clearly in FIGS. 10 and 13, as a surgicalinstrument is withdrawn from the sealing element 18 a, the fluted formbunches beneath the sealing member 48 and thus provides a bracing thatprevents the sealing element 18 a from everting. In some embodiments,the conical walls 136 of the sealing elements 18 b, 18 c do not havefluted forms and instead have a steep angle α relative to a lateralplane of the sealing member 48, as shown in FIG. 8, that resistseversion when a surgical instrument is withdrawn from the sealingelement 18 b, 18 c. As will be appreciated, any of the sealing elements18 can have one or more of the various available constructions for theirrespective sealing membrane 134. As will be appreciated by those skilledin the art, the sealing elements 18 can also be formed as separateelements apart from the sealing member 48 and do not have to be formedintegrally therewith.

The sealing elements 18 can be constructed in various ways, but in theillustrated embodiment, the sealing elements 18 can include upper andlower seal supports 140, 142, shown most clearly in FIG. 4. The upperand lower seal supports 140, 142 can be substantially rigid rings thatare configured to engage upper and lower surfaces of a perimeter of theopening 132 of the sealing member 48 therebetween. The seal supports140, 142 serve to further define the openings formed through the sealingmember 48, provide support thereto for the insertion and withdrawal ofsurgical instruments, and for the movable sealing elements 18 a, 18 b,18 c, can provide a structure that can move, slide, and/or otherwisetravel along and within the tracks 106, 108, 110 in the upper and lowerbearing plates 102, 104.

The upper and lower seal supports 140, 142 can be joined or coupledtogether by any method known in the art including, but not limited to,adhesives, screws, threads, etc. In the illustrated embodiment, thelower seal support 142 includes several cylindrical protrusions 144 andseveral elongate protrusions 146 formed around its circumference andextending in a proximal direction from its proximal surface 148. Thecylindrical protrusions 144 can extend through corresponding openings149 formed around a circumference of the sealing element openings 132 inthe sealing member 48 and into corresponding openings 152 within theupper seal supports 140. The elongate protrusions 146 can extend throughcorresponding elongate slots 150 formed adjacent to the circumference ofthe sealing element openings 132 formed in the sealing member 48. Inthis way, a circumference surrounding each sealing membrane 134 isclamped, coupled, or otherwise secured between the upper and lower sealsupports 140, 142. When mated together, the sealing elements 18 are ableto form an air and gas tight seal around a surgical instrument insertedtherethrough while the sealing member 48 seals the rest of the workingchannel between the upper bearing plate 102 and the interior of a body.

Referring now to FIGS. 9-13, exemplary movement and positioningvariations and configurations of the movable sealing elements 18 a, 18b, 18 c are illustrated. As noted above, the sealing member 48 isflexible and thus will stretch, bunch, twist and otherwise deform inresponse to movement of the various sealing elements 18 a, 18 b, 18 cwithin the upper and lower bearing plate tracks 106, 108, 110. Moreparticularly, because the upper and lower seal supports 140, 142 graspthe sealing member 48 around the sealing membranes 134, the sealingelements 18 a, 18 b, 18 c are able to pull and push the sealing member48 in response to movement of surgical instruments disposed therein.

In the illustrated embodiment, the sealing elements 18 a, 18 b, 18 c areeach independently movable laterally within and along the length and/orwidth of their respective bearing plate tracks 106, 108, 110. Each ofthe sealing elements 18 a, 18 b, 18 c can independently and selectivelybe moved laterally from an initial resting position, such as arelatively center position in the tracks 106, 108, 110 to either ofopposed ends of the tracks 106, 108, 110, and anywhere in between,whether along a straight line of a track 106 or along a curved path thatfollows the curve of tracks 108, 110. In the initial position, the sealmember 48 is not stretched, and in the moved position, the seal member48 stretches to allow a seal to be maintained. The tracks 106, 108, 110containing each sealing element 18 a, 18 b, 18 c define thepredetermined path of movement allowed. For example, in FIGS. 9, 11, and12 a surgical instrument 900 is inserted through the sealing element 18a, which is moved from its natural, center position within the track 106to one end of the track 106 near the outer circumference of the device10. In addition, as shown in FIGS. 11 and 12, a surgical instrument 902is positioned within sealing element 18 b, which is also moved from itsnatural, center position in the track 108 to one end of the track 108. Asurgical instrument 904 is positioned within the sealing element 18 cand is positioned in a center portion of the track 110 in FIG. 11 and ismoved to one end of the track 110 in FIG. 12. Accordingly, somevariations of the possible lateral movement of the sealing elements 18a, 18 b, 18 c within their respective tracks 106, 108, 110 can be seen.Of course, many other variations and combinations of lateral movementare also possible.

Each sealing element 18 a, 18 b, 18 c can also be moved angularly withineach track 106, 108, 110 such that a longitudinal axis of the sealingelement 18 a, 18 b, 18 c is movable and adjustable relative to thecentral longitudinal axis 30 of the housing 12. The sealing elements 18a, 18 b, 18 c can be pivoted out of a lateral plane of the tracks 106,108, 110 within the base member 16. The sealing member 48 can stretchand bunch around each sealing element 18 a, 18 b, 18 c to enable eachsealing element 18 a, 18 b, 18 c to be pivoted to an angle with respectto the lateral plane while maintaining a seal around an instrumentinserted therethrough. In the illustrated embodiments, the sealingelements 18 a, 18 b, 18 c are angularly adjustable at any position alonga lateral, long-axis of the elongate tracks 106, 108, 110. For example,in FIGS. 9 and 10, a central longitudinal axis 930 of the sealingelement 18 a, in which the surgical instrument 900 is disposed, ispositioned at an angle β with respect to the central longitudinal axis30 of the housing 12. As shown in FIGS. 11 and 12, the sealing element18 b, in which the surgical instrument 902 is disposed, is moved from aposition in which its central longitudinal axis 932 is parallel with thecentral longitudinal axis 30 of the housing 12 (FIG. 11) to a positionin which its central longitudinal axis 932 is at an angle γ with respectto the central longitudinal axis 30 of the housing 12 (FIG. 12). At thesame time, a central longitudinal axis 934 of the sealing element 18 cremains parallel with the central longitudinal axis 30 of the housing 12in both configurations. The above described variations in angularadjustment are just a few of the many configurations possible. All ofthe sealing elements 18 a, 18 b, 18 c are completely and independentlyangularly adjustable within their respective tracks 106, 108, 110 at anylateral position within the tracks 106, 108, 110. For example, thesealing elements 18 a, 18 b, 18 c can be angularly adjustable at anyposition along both a long-axis and a short-axis of the elongate tracks106, 108, 110, and/or angularly adjustable at any position around 360degrees laterally within the tracks 106, 108, 110.

The sealing elements 18 a, 18 b, 18 c can also be moved verticallyrelative to the base member 16 and parallel relative to the centrallongitudinal axis 30 of the housing 12. As noted above, in someembodiments, the lips formed in the lower bearing plate tracks 106 b,108 b, 110 b can prevent vertical movement below the bearing platetracks 106 b, 108 b, 110 b, while vertical movement above the upperbearing plate tracks 106 a, 108 a, 110 a is allowed. Thus, a surgicalinstrument disposed within a sealing element 18 a, 18 b, 18 c can bepulled proximally from the sealing element 18 a, 18 b, 18 c, whether forcomplete withdrawal or for adjustment purposes, and the movement canlift the sealing elements 18 a, 18 b, 18 c above the plane of the basemember 16. In other embodiments, vertical movement is allowed in bothdirections above and below the bearing plate tracks 106, 108, 110.

As will be appreciated by those skilled in the art, combinations of anyof the lateral, angular, and vertical movement is also allowed. Aparticular sealing element 18 a, 18 b, 18 c can be independently movedlaterally within a track 106, 108, 110 while its central longitudinalaxis is at an angle relative to the central longitudinal axis 30 of thehousing 12. In addition, a particular sealing element 18 a, 18 b, 18 ccan be independently moved vertically while its central longitudinalaxis is at an angle relative to the central longitudinal axis 30 of thehousing 12. Such vertical movement is thus no longer strictly parallelto the central longitudinal axis 30 of the housing 12, but is insteadmovement that is at an angle relative to the central longitudinal axis30 of the housing 12. Any and all combinations of independent lateral,angular, and vertical movement of each movable sealing element 18 a, 18b, 18 c is accomplished due to the flexibility of the sealing member 48being configured to stretch, twist, bunch, and otherwise deform inresponse to the movement. In addition, all such movement is performedwhile the working channel is sealed due to the seal formed by thesealing elements 18 a, 18 b, 18 c around a surgical instrument insertedtherethrough and due to the flexibility of sealing member 48 that ableto maintain a seal during deformation.

As noted above, the base member 16 can also be rotated within andrelative to the base member support 44, and thus relative to the housing12. Accordingly, the base member 16 provides multiple ways in which thesealing elements 18 can be moved to provide better access for surgicalinstruments inserted therein. By rotating the base member 16, thesealing elements 18 can all be rotated as a collective unit around thecentral longitudinal axis 30 of the housing 12. In addition, eachsealing element 18 a, 18 b, 18 c can be moved laterally, angularly, andvertically within the base member 16, as described above, to enablebetter access and maneuverability.

FIGS. 14-17 illustrate one embodiment of the range of motion that thesurgical access device 10 can provide during surgical procedures. Inparticular, FIGS. 14-16 illustrate a series of possible ranges of motionfor various positions of the sealing elements 18. FIG. 17 combines thethree series shown in FIGS. 14-16 to give a complete picture of oneembodiment of the range of motion possible with the surgical accessdevice 10. In all illustrations, an assumption is made that a firstsurgical instrument 940, disposed through the sealing element 18 c,remains perpendicular to a lateral axis or a lateral surface of thehousing 12 as a second surgical instrument 942, disposed through thesealing element 18 b, is moved through various angles relative to thelateral axis or the lateral surface of the housing 12.

In FIG. 14, a target diameter 944 is illustrated and represents thetarget space over which one or both of the first and second surgicalinstruments 940, 942 can move during a surgical procedure. The firstsurgical instrument 940 is positioned through the sealing element 18 c,which is positioned at a left-hand end of the track 110. The secondsurgical instrument 942 is positioned through the sealing element 18 b,which is positioned at a left-hand end of the track 108. The two sealingelements 18 c, 18 b are positioned at the same, left-hand end of thetracks 110, 108. In this position, there is a triangular shaped space946 a behind the surgical instrument 940 that cannot be accessed by anyangular movement of the second instrument 942. As the second surgicalinstrument 942 is moved through its entire angular range, it will passover the first surgical instrument 940, as illustrated by the arrow B. Akey-hole shape 948 a is also shown and generally illustrates the areaover which the instrument 942 cannot reach while in this lateralposition within the track 108 due to, for example, handle and shaftinterference between the two instruments 940, 942. Thus, the entiretarget diameter 944, minus the triangle 946 a and the key-hole shape 948a, can be reached by the second surgical instrument 942 during asurgical procedure while the sealing elements 18 c, 18 b are in the far,left-hand end position within their tracks 110, 108.

In FIG. 15, the target diameter 944 is again illustrated. The firstsurgical instrument 940 is positioned through the sealing element 18 c,which is positioned at a center portion of the track 110. The secondsurgical instrument 942 is positioned through the sealing element 18 b,which is positioned at a center portion of the track 108. In thisposition, there is a triangular shaped space 946 b behind the firstsurgical instrument 940 that cannot be accessed by any angular movementof the second surgical instrument 942. As the second surgical instrument942 is moved through its entire angular range, it will pass over thefirst surgical instrument 940, as illustrated by the arrow B. A key-holeshape 948 b is also shown and generally illustrates the area over whichthe second surgical instrument 942 cannot reach while in this center,lateral position within the track 108 due to, for example, handle andshaft interference between the two instruments 940, 942. Thus, theentire target diameter 944, minus the triangle 946 b and the key-holeshape 948 b, can be reached by the surgical instrument 942 while thesealing elements 18 c, 18 b are in center positions within theirrespective tracks 110, 108.

In FIG. 16, the target diameter 944 is again illustrated. The firstsurgical instrument 940 is positioned through the sealing element 18 c,which is positioned at a right-hand end of the track 110. The secondsurgical instrument 942 is positioned through the sealing element 18 b,which is positioned at a right-hand end of the track 108. The twosealing elements 18 c, 18 b are positioned at the same, right-hand endof the tracks 110, 108. In this position, there is a triangular shapedspace 946 c behind the first surgical instrument 940 that cannot beaccessed by any angular movement of the second surgical instrument 942.As the second surgical instrument 942 is moved through its entireangular range, it will pass over the first surgical instrument 940, asillustrated by the arrow B. A key-hole shape 948 c is also shown andgenerally illustrates the area over which the second surgical instrument942 cannot reach while in this lateral position within the track 108 dueto, for example, handle and shaft interference between the twoinstruments 940, 942. Thus, the entire target diameter 944, minus thetriangle 946 c and the key-hole shape 948 c, can be reached by thesecond surgical instrument 942 during a surgical procedure while thesealing elements 18 c, 18 b are in the far, right-hand end positionwithin their tracks 110, 108.

As noted above, FIG. 17 represents the combination of FIGS. 14-16 toillustrate one embodiment of the full range of motion available during asurgical procedure to the second surgical instrument 942 disposedthrough the surgical access device 10. The target diameter 944 is againshown. An area 946, enclosed by dotted lines, represents the combinationof triangles 946 a, 946 b, 946 c and is essentially an area where asmall portion of the target diameter 944 becomes unavailable to thesecond surgical instrument 942 at each lateral position within the track108 due to, for example, interference between the two shafts. An area948 is a combination of the key-holes 948 a, 948 b, 948 c and is theonly area within the target diameter 944 that can be unavailable to thesecond surgical instrument 942 during a surgical procedure. Accordingly,almost the entire target diameter 944 is accessible to the secondsurgical instrument 942, while another surgical instrument 940 isdisposed through the surgical access device 10, just by moving thesecond surgical instrument 942 along the track 108 and through thevarious possible angular orientations. Of course, the inaccessible area948 is accessible by another surgical instrument disposed through thesealing element 18 c and/or 18 a. In addition, as noted above, the basemember 16 is rotatable relative to the rest of the housing 12, and thuswith a slight rotation of the base member 16, the second surgicalinstrument 942 can access the area 948. Additionally, the entire housing12 is rotatable relative to the retractor 28, providing a similar typeof access to the second surgical instrument 942. As will be appreciated,this series of range of motion illustrations is only one example of manypossible ranges of motion that the surgical access device 10 canprovide.

In use, as shown in FIGS. 18-20, the retractor 28 of the exemplaryaccess device 10 can be positioned within any opening in a patient'sbody, including natural openings and surgically formed openings. In theillustrated embodiment, the retractor is positioned through an openingwithin tissue 19. The retractor 28 is held in place by the tissue 19within the opening such that the housing 12 is positioned against anouter surface of the patient's body. Before insertion of any surgicalinstruments into the housing 12, the housing 12 can be rotated in eitherdirection by any amount relative to the retractor 28 to enable properpositioning of the sealing elements 18. Once a proper position isachieved, various surgical instruments, for example surgical instrument27, can be inserted through the movable and immovable sealing elements18 disposed within the housing 12 and into the working channel of thesurgical access device.

In the illustrated embodiment, one sealing element 18 a has a diameterthan is larger than the other sealing elements 18 b, 18 c, 18 d. Thus,the sealing element 18 a can receive the surgical instrument 27 having alarger diameter, such as an endoscopic camera and/or light. In addition,in the illustrated embodiment, the immovable sealing element 18 d has adiameter smaller than the other sealing elements 18 a, 18 b, 18 c andcan receive an instrument with a smaller diameter, for example, asurgical retractor. The other two movable sealing elements 18 b, 18 ccan receive any number of other surgical instruments as may be needed ina particular application. A person skilled in the art will appreciatethat the sealing elements 18 can have various diameter and that anysurgical instrument having a suitable diameter can be inserted in anyone of the various sealing elements.

Once surgical instruments are disposed within the sealing elements 18 asneeded, insufflation of the interior surgical site can be achieved byflowing an insufflation gas through the insufflation port 56 and intothe sealed working channel. The surgical instruments within the sealingelements 18 a, 18 b, 18 c can then be moved laterally, angularly, andvertically, as described above, to achieve optimal positioning of thesurgical instruments within the interior surgical site. In addition, thebase member 16 can be rotated relative to the base member support 44 andthe housing 12 to rotate all of the sealing elements 18, and theinstruments disposed in the sealing elements 18, as a collective unit.The housing 12 can also be rotated as needed to achieve betterpositioning for, for example, the insufflation port 56. During thesurgical procedure, the surgical instruments disposed in the sealingelements 18 can be repeatedly and independently moved and manipulatedwithin their respective tracks 106, 108, 110 to facilitate ease of use.

Upon completion of a surgical procedure, insufflation pressure can bereleased through the insufflation port 56, and the surgical instrumentscan be withdrawn from the sealing elements. Using the latches 24, a topportion 11 of the housing 12, including the housing cover 14, the basemember 16, and the base member support 44, can be unlatched and removedfrom the housing support 42, as shown most clearly in FIG. 20. Theretractor 28 remains within the opening in the tissue 19 and the housingsupport 42 remains adjacent to the tissue 19 on an exterior thereof.Tissue 43 that was cut or dissected during the surgical procedure can bewithdrawn through the working channel of the retractor 28 as neededusing a surgical instrument 49. The retractor 28 can then be removedfrom the opening in the tissue 19 upon completion of the procedure. Aswill be appreciated, the top portion 11 of the housing 12 can also belatched back to the housing support 42 as needed if further surgicalprocedures are required.

In some embodiments, such as that shown in FIGS. 21-28, the surgicalaccess device 10 can also include a shield 719 configured to extendthrough the retractor 28 to thereby provide a protective lining assurgical instruments are inserted through the device 10. The shield 719can have a length corresponding to a length of the retractor 28, but canalso have a length less than or considerably longer than the length ofthe retractor depending on a specific application. The shield 719 can bemated to the retractor 28 using any attachment mechanism, e.g.,adhesive, screws, press fit, etc., as will be appreciated by a personskilled in the art. As illustrated, the shield 719 can be configured toengage a proximal flange 32 of the retractor 28 that is seated in thehousing support 42 and the distal surface 86 of the base member support44. The proximal o-ring 38 within the flange 32 can help providestructure to the proximal flange 32 and therefore help provide a morestable engagement surface for the shield 719. Lips 720 a, 720 b can beformed around an outer circumference of a proximal rim 718 of the shield719 and can fit within and engage a recess 722 formed in the distalsurface 86 of the base member support 44 to provide further securementof the shield 719 between the proximal flange 32 and the base membersupport 44.

The shield 719 can have any size, shape, and configuration. In thisillustrated embodiment, the shield 719 includes a circumferentiallyexpandable, cylindrically-shaped member having an outer layer 719 a andan inner layer 719 b configured to be disposed within in the outer layer719 a. The outer and inner layers 719 a, 719 b can each respectivelyinclude a circumferential proximal rim 721 a, 721 b having a pluralityof flanges 723 a, 723 b extending radially outward therefrom. The outerand inner layers 719 a, 719 b can include any number of flanges 723 a,723 b, and the flanges 723 a, 723 b can be spaced equidistantly or anyother distance apart from one another around their respective proximalrims 721 a, 72 lb. The outer and inner flanges 723 a, 723 b can each beconfigured to at least partially overlap to form a continuous proximalflange of the shield 719 that is configured to engage the proximalflange 32 of the retractor 28. Alternatively, as shown, a portion of theouter and inner flanges 723 a, 723 b can be configured to engage oneanother to form a “broken” proximal flange of the shield 719. In otherembodiments, none of the outer and inner flanges 723 a, 723 b canoverlap one another when the inner layer 719 b is disposed in the outerlayer 719 a.

The outer and inner layers 719 a, 719 b of the shield 719 can alsoinclude a plurality of respective distal elongate fingers 725 a, 725 bdistally extending from the proximal rim 721 a, 721 b and configured toat least partially overlap and engage one another when the inner layer719 b is disposed in the outer layer 719 a to form a continuous distalsurface configured to engage at least a portion of an inner wall of theinner elongate portion 36 of the retractor 28. The distal fingers 725 a,725 b can thus be configured to protect the inner elongate portion 36 ofthe retractor 28 from damage but be configured to be selectively movablewhen in contact with a surgical instrument such that the surgicalinstrument can optionally push between the distal fingers 725 a, 725 bto help provide the surgical instrument with free angular range ofmotion through the device 10. The distal fingers 725 a, 725 b can alsobe configured to be selectively movable when the retractor 28 bends whenin position in tissue, if the retractor 28 is flexible.

A shield can include a plurality of layers as discussed above, or ashield can be a singular member, which can make the shield easier todispose in a retractor. FIGS. 24 and 25 illustrate one embodiment of asingular shield 719′. The alternate shield 719′ can include acircumferential proximal rim 721′ with or without radially extendingflanges and with a lip 720′ for mating with the device 10, as describedabove. Instead of having a plurality of fingers distally extending fromthe proximal rim 721′, the alternate shield 719′ can include a pleateddistal portion 723′ that simulates distal fingers. The pleated distalportion 723′ can have a variety of sizes, shapes, and configurations. Asshown, the pleated distal portion 723′ can include a plurality of boxpleats 723 a′ folded in the shield 719′ circumferentially around thedistal portion 723′. In this way, the pleated distal portion 723′ can beconfigured to be selectively movable when the retractor 719′ bends, ifthe retractor 719′ is flexible, and/or when a surgical instrumentpresses against an inner wall of the pleated distal portion 723′. Inanother embodiment of a singular retractor shield 719″, shown in FIGS.26-28, the shield 719″ can include a pleated distal portion 723″distally extending from a proximal rim 721″ having a lip 720″ and havinga plurality of knife pleats 723 a″ formed circumferentially therearound.As will be appreciated, any type of shield can be used as needed in aparticular application and can be interchanged before, during, and/orafter a procedure as needed.

Other exemplary surgical access devices are also provided. In oneembodiment shown in FIGS. 29A and 29B, a base member 200 of a housingfor a surgical access device is provided having three sealing elements202 attached or coupled to independently slidably rotatable rims 204 a,204 b, 204 c. As shown, the three slidably rotatable rims 204 a, 204 b,204 c are provided concentrically adjacent to one another near an outercircumference of the base member 200. The rotatable rims 204 a, 204 b,204 c can each have an elongate sealing element arm 205 extendingradially therefrom. The rotatable rims 204 a, 204 b, 204 c can beindependently rotatable, thus allowing the sealing element arms 205extending therefrom to be rotatable relative to the other sealingelement arms 205 coupled to the other rims 204 a, 204 b, 204 c. Duringuse, a particular sealing element arm 205 can be rotated by a surgicalinstrument disposed therein, which causes the rim 204 a, 204 b, 204 c torotate relative to the other rims 204 a, 204 b, 204 c. In this way,independent rotation of the sealing elements 202 relative to each otherand relative to the base member 200 can be achieved.

In some embodiments, a flexible sealing member can form at least acenter portion of the base member 200, and sealing membranes of eachsealing element 202 can be integrally formed with the sealing member.The sealing membranes can be, for example, flexible, conically shapedelements that are configured to receive and form a seal around aninstrument inserted therethrough. The sealing member can stretch, twist,bunch, and otherwise deform to allow movement of the sealing elements202 around the base member 200 while maintaining a seal across a workingchannel of the access device. In addition to lateral, rotationalmovement of the sealing elements 202 around the circumference of thebase member 200, the sealing elements 202 can also be moved angularlywith respect to a central longitudinal axis of the base member 200, asshown in FIG. 29A, and vertically parallel to the central longitudinalaxis of the base member. In some embodiments, the flexible sealingmember can form just a center portion of the base member 200. In otherembodiments, the flexible sealing member can form an entire layer of thebase member 200.

An exemplary mechanism for accomplishing rotation of three independentrims is shown most clearly in FIG. 29B. As shown, three tracks orgrooves 214 can be formed around an outer circumference of the basemember 200 and can each receive a slidably rotatable rim 204 a, 204 b,204 c. Each rotatable rim 204 a, 204 b, 204 c can move or slide withinits groove 214 to accomplish rotation. Each sealing element 202 can beattached to one of the rotatable rims 204 a, 204 b, 204 c and canthereby be rotated around the circumference of the base member 200. Inother embodiments, each rim 204 a, 204 b, 204 c can simply be positionedadjacent to one another such that the rims 204 a, 204 b, 204 c areslidably rotatable relative to each other around the circumference ofthe base member 200. A person skilled in the art will appreciate thevarious methods of accomplishing rotation of the rims 204 a, 204 b, 204c.

An optional locking mechanism 216 is illustrated in FIG. 30 that canenable a position of the rotatable rims 204, and thereby the sealingelements 202, to be locked and/or secured. As shown, each rotatable rim204 and each groove 214 can be divided into two portions. The end ofeach portion of the rotatable rim 204 can have an opening 218 formedtherein for receiving a selectively movable latch 220 that joins the twosections together. When the latch 220 is up or disengaged, a bottomportion 222 of the latch 220 is raised to allow the rotatable rim 204 tobe moved within its corresponding groove 214 and around thecircumference of the base member 200. When the latch 220 is lowered orengaged, and when the latch 220 is within a space dividing the groove214, the bottom portion 222 of the latch 220 is lower than the groove214 and cannot be moved within the groove 214, thereby preventingmovement of the rotatable rim 204.

Another exemplary embodiment of a base member 300 for a surgical accessdevice is illustrated in FIGS. 31A-31E. The base member 300 is similarto that described above in FIGS. 29A-29B, but includes an additionalfeature enabling adjustment of a radial length of an elongate member 304of a sealing element 302 extending into a center of the base member 300.One or more slots 312 can be formed in each rotatable rim 310 to receivethe elongate member 304 of the sealing element 302. An adjustmentmechanism in the form of a flexible lever 314 can be inserted throughthe slots 312 in the rotatable rims 310 to thereby secure a radiallength of the elongate member 304. In the unflexed position, theflexible lever 314 can engage sides of the slot 312 to prevent radialadjustment of the elongate member 304. By squeezing grips 311, a widthof the flexible lever 314 can be decreased so that the radial length ofthe elongate member 304 can be adjusted. For example, the elongatemember 304 of the sealing element 302 can be made longer by sliding theelongate member 304 inward within the slot 312 to thereby move thesealing element 302 further into a center portion of the base member300. In other embodiments, the elongate member 304 of the sealingelement 302 can be shortened by sliding the elongate member 304 outwardwithin the slot 312 to thereby pull the sealing element 302 toward theouter circumference of the base member 300 and away from the centerportion.

The sealing elements 302 can each be disposed through and/or formedintegrally with a flexible sealing member, similar to those describedabove, which allows for the radius of each sealing element 302 to beadjusted. As the sealing elements 302 are each moved inward and/oroutward relative to the outer circumference of the base member 300, thesealing member can bunches, stretches, twists, and otherwise deforms asneeded to allow movement of the sealing element 302 while maintaining anair and gas tight seal across the working channel of the housing. Inaddition to radial length adjustments, the sealing elements 302 can alsobe independently rotated via the rotatable rims 310, as described above,and as also facilitated by the flexible sealing member. As with otherembodiments, the sealing elements 302 can each be independently movedlaterally, angularly, and vertically as needed due to the flexibility ofthe sealing member 320.

In another embodiment shown in FIGS. 32A and 32B, a flexible retractor330 is positioned within tissue 332. A housing 334 is positioned withinthe retractor 330 and seats a rotatable base member 336 having a sealingelement 338 formed therein. In some embodiments, the rotatable basemember 336 can be generally flush with a top surface of the housing 334as shown, for example, in FIG. 32A. In other embodiments, the basemember 336 can extend distally at an angle with respect to the topsurface of the housing 334 such that the sealing element 338 is in arecessed positioned relative to the top surface of the housing, asshown, for example, in FIG. 32B. As will be appreciated, the base member336 can also have a semi-flexible or completely flexible sealingmembrane to enable the sealing element 338 to be moved between a flushposition and a recessed position.

Another exemplary embodiment of a base member 400 of a surgical accessdevice is illustrated in FIGS. 33A and 33B. The base member 400 caninclude one or more rotatable pathways, for example two pathways 402,404, extending around the base member 400 at different radii. One ormore sealing elements, for example, sealing elements 406 a and 406 b,can be disposed within each rotatable pathway 402, 404 and can berotated 360 degrees around the base member 400 within their respectivepathways 402, 404. Each pathway 402, 404 contains a flexible membrane,for example a flexible bellows, that can compress and expand in responseto movement of the sealing elements 406 a, 406 b. Accordingly, assealing elements 406 a are moved along pathway 402, the flexible bellowsor other flexible membrane can bunch and compress to allow independentmovement of each sealing element 406 a or 406 b independent of theother. In some embodiments, a sealing element 406 c can be positioned ina center portion of the base member 400.

Another exemplary embodiment of a surgical access device 500 isillustrated in FIGS. 34A and 34B. As shown, the surgical access deviceincludes three base members 502, 504, 506 disposed within a housing 510.The three base members 502, 504, 506 are generally positioned verticallywithin the housing 510, one on top of another, and separated by adistance. In each base member 502, 504, 506, a sealing element 512, forexample a gimbal type seal, is disposed therein and positioned, forexample, on one side of each base member 502, 504, 506. A flexiblesealing member 514 with various openings formed therein and having asubstantially crescent or moon-like shape can be positioned on a side ofthe base members 502, 504, 506 opposite to the sealing element 512. Insome embodiments, the sealing member 514 can be a slit seal having twothin, overlapping silicone or urethane pieces that allow a seal to bemaintained between each of the three base members 502, 504, 506 when aninstrument is passed therethrough. Each base member 502, 504, 506 can bedisposed within the housing 510 in such a way that the sealing elements512 and the sealing members 514 are slightly offset from one another. Inaddition, each base member 502, 504, 506 can be rotatable relative tothe housing 510 to enable adjustment of their position relative to oneanother. As shown in FIG. 34B, the sealing elements 512 and sealingmembers 514 are offset so that a surgical instrument can be insertedthrough all three base members 502, 504, 506 and have a range of motionwithin its respective base member 502, 504, 506 relative to the otherbase members 502, 504, 506.

For example, a first surgical instrument 516 can be inserted into thesealing element 512 in the top or proximal most base member 506. Thefirst surgical instrument 516 extends through the sealing element 512and through the openings in the flexible sealing members 514 of thebottom two base members 502, 504. The first surgical instrument 516 issealed within the sealing element 512 in the top base member 506 and canbe moved laterally within the sealing members 514 of the bottom two basemembers 502, 504 to enable greater maneuverability. A second surgicalinstrument 518 can be inserted through the sealing member 514 of the topbase member 506, into the sealing element 512 of the middle base member504, and through the sealing member 514 of the bottom base member 502.Similar to the first surgical instrument 516, the second surgicalinstrument 518 can move laterally within the sealing members 514 of thetop and bottom base members 506, 502 and is sealed within the sealingelement 512 of the middle base member 504. Likewise, a third surgicalinstrument 520 can be inserted through the sealing members 514 of thetop and middle base members 506, 504 and into the sealing element 512 ofthe bottom base member 502. The third surgical instrument 520 can belaterally movable relative to the top and middle base members 506, 504and is sealed within the sealing element 512 formed in the bottom basemember 502. In this way, each surgical instrument 516, 518, 520 has agreater range of maneuverability within the surgical access device 500.

Another embodiment is shown in FIGS. 35A and 35B. A base member 350 isprovided having a plurality of rotatable rings 352 that can bepositioned on top of a base member support 354. Each ring 352′, 352″,352′″ can include a movable arm 356 having a sealing element 358disposed therein. The arm 356 can be radially adjustable to move thesealing element 358 between an outer circumference of the base member350 and a center portion of the base member 350 by any mechanism knownin the art. For example, a simple press fit or interference fit canexist between the arm 356 and the rings 352′, 352″, 352′″ such that thearm can be held in place using friction and can be manually movedrelative to the rings 352′, 352″, 352′″ as needed. In addition, thesealing elements 358 can be movable angularly relative to the movablearm 356 to allow angular movement of a surgical instrument disposedtherethrough. A flexible seal member 360′, 360″, 360′″ can form the acenter portion of each ring 352′, 352″, 352′″ and can bunch, stretch,and deform to allow the sealing elements 358 to move with the surgicalinstruments.

In a further embodiment shown in FIGS. 36A and 36B, a base member 430 isprovided having a plurality of rotatable rings. A top rotatable ring 432can contain a flexible sealing member 434, similar to the flexiblemembranes described herein. In addition, in some embodiments, thesealing member 434 can include one or more sealing elements 442 disposedtherethrough that can be integrally formed with the flexible sealingmember 434. One or more other rotatable rings 436, for example, threerings 436′, 436″, 436′″ each can have sealing arms 438 extendingtherefrom and can be stacked one on top of the other beneath the sealingmember 434. Each ring 436 can be individually rotatable relative to theother rings 436′, 436″, 436′″ and relative to the sealing member 434.Each of the sealing arms 438 can include a sealing element 440positioned at one end thereof and configured to form a seal around aninstrument inserted therethrough. In use, for example, an instrument canbe inserted through the sealing element 442 in the sealing member 434,and into one of the sealing elements 440 in one of the rings 436. Theinstrument can be used to rotate each ring 436 as needed in a procedure,and the sealing member can flex, stretch, and bunch to allow theinstrument to move while still maintaining a seal around the instrument.

Another exemplary embodiment of a surgical access device 800 is shown inFIGS. 39A-39B. The surgical access device 800 can have a housing 814with one or more, for example three, triangular-shaped base members 802,804, 806 stacked one on top of another. Each base member 802, 804, 806can have at least one sealing element 808 and one or more, for exampletwo, slit seals 810 disposed therein. Similar to the embodimentillustrated in FIG. 34A and 34B, surgical instruments can be insertedthrough the sealing element 808 in one base member 802, 804, 806 and canextend through the slit seals 810 in the other two base members to allowmovement of the instrument within the sealing element 808 relative tothe other base members while a seal is maintained. In addition, tracks812 extending around the circumference of each base member 802, 804, 806allows the base members 802, 804, 806 to be rotatable relative to eachother and relative to the housing 814.

In any of the embodiments described herein, any type of seal known inthe art can be used to form a seal around a surgical instrument and/orto seal a channel of the sealing element such that a seal is formed whenno instrument is inserted therethrough. Conical seals, such as thoseshown in FIGS. 5 and 6, can be used to form a seal around an instrumentand are simply composed of conically shaped flexible membrane have anopening at an apex of the cone. In some embodiments, a gimbal seal, suchas that shown in FIGS. 37A-37D, can be used. A gimbal seal can include aframe 450 that connects a sealing element 452 to a base member 454. Thesealing element 452 can include a gimbal 456 and a sealing membrane 458extending from the gimbal 456. The gimbal 456 can rotate and move in alldirections within the frame 450 to allow a full range of movement for asurgical instrument inserted through the sealing element 452. Thesealing membrane 458 can form a seal around an instrument insertedtherethough and generally does not form a seal when no instrument isinserted therethrough.

In other embodiments, sealing elements can take the form of amulti-layer conical instrument seal. The multi-layer conical seal cangenerally include a series of overlapping seal segments that areassembled in a woven arrangement to provide a complete seal body. Aprotective member can be positioned adjacent to the multi-layer conicalseal to protect the seal from sharp instruments being insertedtherethrough. The multi-layer conical seal and/or the protector can beformed of elastomeric materials and/or from a molded thermoplasticpolyurethane elastomer, such as Pellethane™. Exemplary instrument sealconfigurations are described in more detail in U.S. Publication No.2004/0230161 entitled “Trocar Seal Assembly,” filed on Mar. 31, 2004,and U.S. application Ser. No. 10/687,502 entitled “Conical Trocar Seal,”filed on Oct. 15, 2003, which are hereby incorporated by reference intheir entireties.

Another type of sealing element that can be used in the surgical accessdevices described herein is the channel or zero-closure seal. Thezero-closure seal can be, for example, in the form of a duckbill sealthat is configured to form a seal in a working channel when noinstrument is disposed therethrough to thus prevent the leakage ofinsufflation gases delivered through the surgical access device to thebody cavity. The duckbill seal can generally have opposed flaps thatextend at an angle toward one another in a distal direction and thatcome together at a distal end to form a seal face. The opposed flaps canbe movable relative to one another to allow the seal face to movebetween a closed position, in which no instrument is disposedtherethrough and the seal face seals the working channel of the surgicalaccess device, and an open position in which an instrument is disposedtherethrough. The seal can include various other features, as describedin more detail in U.S. application Ser. No. 11/771,263, entitled“Duckbill Seal with Fluid Drainage Feature,” filed on Jun. 29, 2007,which is hereby incorporated by reference in its entirety. In addition,the seal face of the duckbill seal can be in any nonlinear shape orconfiguration known in the art, for example in an S-shapedconfiguration, as described in more detail in U.S. Pat. No. 5,330,437,entitled “Self Sealing Flexible Elastomeric Valve and Trocar Assemblyfor Incorporating Same,” filed Nov. 12, 1993, which is herebyincorporated by reference in its entirety.

In accordance with the present disclosure, the general structure of theseals do not generally form part of the present invention. As such, aperson skilled in the art will certainly appreciate that any and allsealing elements and sealing configurations known in the art can be usedwithin the surgical access device embodiments disclosed herein withoutdeparting from the spirit of the invention disclosed.

As will also be appreciated by those skilled in the art, any and all ofthe base members embodiments disclosed herein can be interchangeablewith one another as needed. For example, an exemplary surgical accessdevice kit could include multiple housings and base members with one ormore retractors. Each base member and housing combination can havedifferent pathway and/or track configurations enabling variouscombinations of sealing element movement as needed in particularapplication. Various release mechanisms known in the art can be used toreleasably attach the various base members and housings to a retractor.

As surgical instruments are inserted through the surgical access deviceembodiments described herein, a risk can exist that a particularly sharpinstrument may tear or puncture a portion of the retractor or nearbytissue. Accordingly, in any and all of the embodiments described herein,a safety shield can optionally be included to reduce the risk of tearingor puncture by a surgical instrument. In general the shield can be of amaterial that is relatively smooth to allow ease of passage ofinstruments, but resistant to tearing and puncture. For example, theshield can formed of silicone, urethane, thermoplastic elastomer,rubber, polyolefins, polyesters, nylons, fluoropolymers, and any othersuitable materials known in the art. The shield can generally provide aliner for a retractor or tissue and can be detachable from a surgicalaccess device so it can be used as needed in a particular procedure.

There are various features that can optionally be included with any andall of the surgical access device embodiments disclosed herein. Forexample, a component of the device, such as a base member, housing,retractor, etc., can have one or more lights formed thereon or around acircumference thereof to enable better visualization when insertedwithin a patient. As will be appreciated, any wavelength of light can beused for various applications, whether visible or invisible. Any numberof ports can also be included on and/or through the surgical accessdevices to enable the use of various surgical techniques and devices asneeded in a particular procedure. For example, openings and ports canallow for the introduction of pressurized gases, vacuum systems, energysources such as radiofrequency and ultrasound, irrigation, imaging, etc.As will be appreciated by those skilled in the art, any of thesetechniques and devices can be removably attachable to the surgicalaccess device and can be exchanged and manipulated as needed.

The embodiments described herein can be used in any known and futuresurgical procedures and methods, as will be appreciated by those skilledin the art. For example, any of the embodiments described herein can beused in performing a sleeve gastrectomy and/or a gastroplasty, asdescribed in U.S. application Ser. No. 12/242,765 entitled “SurgicalAccess Device” filed on Sep. 30, 2008; U.S. application Ser. No.12/242,711 entitled “Surgical Access Device with Protective Element”filed on Sep. 30, 2008; U.S. application Ser. No. 12/242,721 entitled“Multiple Port Surgical Access Device” filed on Sep. 30, 2008; U.S.application Ser. No. 12/242,726 entitled “Variable Surgical AccessDevice” filed on Sep. 30, 2008; U.S. application Ser. No. 12/242,333entitled “Methods and Devices for Performing Gastrectomies andGastroplasties” filed on Sep. 30, 2008; U.S. application Ser. No.12/242,353 entitled “Methods and Devices for Performing Gastrectomiesand Gastroplasties” filed on Sep. 30, 2008; and U.S. application Ser.No. 12/242,381 entitled “Methods and Devices for PerformingGastroplasties Using a Multiple Port Access Device” filed on Sep. 30,2008, all of which are hereby incorporated by reference in theirentireties.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination,e.g., a sealing element, sealing member, base member, a housing, aretractor, etc. Upon cleaning and/or replacement of particular parts,the device can be reassembled for subsequent use either at areconditioning facility, or by a surgical team immediately prior to asurgical procedure. Those skilled in the art will appreciate thatreconditioning of a device can utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. Use of suchtechniques, and the resulting reconditioned device, are all within thescope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam, and a liquid bath (e.g., cold soak).In addition, individual components of the devices described herein canbe sterilized separately. For example, a surgical access device of theinvention can be deconstructed into its individual component pieces,such as the housing cover, the housing support, the base member support,and/or the various components of the base member, and each can besterilized using any of the above described techniques.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical method, comprising: moving a firstsealing element within a first hole formed in a base member of an accessdevice relative to a second sealing element, thereby causing deformationof a flexible member in which the first sealing element is seated in asealing relationship, the flexible member forming a fluid seal of aworking channel of a retractor of the access device; and moving thesecond sealing element within a second hole formed in the base member,thereby causing deformation of the flexible member in which the secondsealing element is seated in a sealing relationship.
 2. The method ofclaim 1, wherein moving the first sealing element within the first holealso moves the first sealing element with a first opening formed in theflexible member in which the first sealing element is seated in thesealing relationship, the first opening being aligned with the firsthole; and moving the second sealing element within the second hole alsomoves the second sealing element with a second opening formed in theflexible member in which the second sealing element is seated in thesealing relationship, the second opening being aligned with the secondhole.
 3. The method of claim 2, wherein the first opening has an areathat is less than an area of the first hole, and the second opening hasan area that is less than an area of the second hole.
 4. The method ofclaim 1, wherein the movement of the first sealing element within thefirst hole is caused by movement of a first surgical instrumentextending through the first sealing element in a sealing relationship,and the movement of the second sealing element within the second hole iscaused by movement of a second surgical instrument extending through thesecond sealing element in a sealing relationship.
 5. The method of claim4, wherein the first and second surgical instruments each extend throughthe working channel.
 6. The method of claim 1, wherein the movement ofthe first sealing element within the first hole includes moving thefirst sealing element vertically with respect to a plane defined by ahorizontal surface of the flexible member in which the first and secondopenings are formed.
 7. The method of claim 1, wherein the movement ofthe first sealing element within the first hole includes moving thefirst sealing element horizontally along to a plane defined by ahorizontal surface of the flexible member in which the first and secondopenings are formed.
 8. A surgical method, comprising: positioning asurgical access device in tissue of a patient, the surgical accessdevice including a housing with a plurality of tracks formed therein, adeformable member defining a horizontal plane, and a plurality ofsealing elements each configured to form a seal around an instrumentinserted therethrough; moving a first one of the plurality of sealingelements within a first one of the tracks; moving the first one of theplurality of sealing elements horizontally along the horizontal planewithin the first one of the tracks relative to a remainder of theplurality of sealing elements, the horizontal movement of the first oneof the plurality of sealing elements causing deformation of thedeformable member; and moving the first one of the plurality of sealingelements vertically out of the horizontal plane relative to a remainderof the plurality of sealing elements, the vertical movement of the firstone of the plurality of sealing elements causing deformation of thedeformable member.
 9. The method of claim 8, wherein the deformablemember provides a fluid seal.
 10. The method of claim 9, wherein thedeformable member includes a deformable membrane.
 11. The method ofclaim 8, wherein the vertical movement of the first one of the pluralityof sealing elements includes at least one of vertical movement in afirst direction away from a retractor coupled to the housing andvertical movement in a second direction toward the retractor.
 12. Themethod of claim 11, further comprising positioning the retractor intissue of a patient to allow access through the tissue to inside thepatient's body.
 13. The method of claim 11, wherein the deformable sealprovides a fluid seal of an inner lumen of the retractor throughout thevertical movement of the first one of the plurality of sealing elements.14. The method of claim 8, further comprising: moving a second one ofthe plurality of sealing elements within a second one of the tracks;moving the second one of the plurality of sealing elements horizontallyalong the horizontal plane within the second one of the tracks relativeto a remainder of the plurality of sealing elements, the horizontalmovement of the second one of the plurality of sealing elements causingdeformation of the deformable member; and moving the second one of theplurality of sealing elements vertically out of the horizontal planerelative to a remainder of the plurality of sealing elements, thevertical movement of the second one of the plurality of sealing elementscausing deformation of the deformable member.
 15. A surgical device,comprising: a retractor configured to be positioned in tissue and havinga pathway extending therethrough; a plurality of rotatable membersdisposed in a housing and each configured to rotate relative to theretractor and relative to one another about a central longitudinal axisof the retractor, each rotatable member having a sealing element coupledthereto and configured to rotate therewith, each sealing element beingconfigured to receive a surgical instrument therethrough to pass intothe pathway, and each sealing element being configured to form a sealaround the surgical instrument received therethrough; and a lockconfigured to lock at least one of the rotatable members in rotatedposition relative to the retractor and thereby lock the sealing elementof the at least one rotatable member in rotated position relative to theretractor.
 16. The device of claim 15, further comprising a track;wherein the lock is configured to move between an unlocked position, inwhich the lock is configured to slide within the track and allow the atleast one rotatable member to rotate relative to the retractor, and alocked position, in which the lock is prevented from sliding within thetrack and is configured to prevent the at least one rotatable memberfrom rotating relative to the retractor.
 17. The device of claim 16,wherein the track is formed in an inner surface of the housing.
 18. Thedevice of claim 15, wherein the lock includes a latch, and each of therotatable members includes a ring.
 19. The device of claim 15, whereinthe retractor is flexible.
 20. The device of claim 15, wherein each ofthe rotatable members are in a vertical stack with the retractor beingvertically below the rotatable members.